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Phentermine has some similarity in its pharmacodynamics with
its parent compound, amphetamine, as they both are TAAR1 agonists, where
the activation of TAAR1 in monoamine neurons facilitates the efflux
or, release into the synapse, of these neurochemicals; at clinically relevant
doses, phentermine primarily acts as a releasing agent of norepinephrine in neurons,
although, to a lesser extent, it releases dopamine and serotonin into
synapses as well. Phentermine may also trigger the release of monoamines
from VMAT2, which is a common pharmacodynamic effect among substituted
amphetamines. The primary mechanism of phentermine's action in treating obesity
is the reduction of hunger perception, which is a cognitive process mediated
primarily through several nuclei within the hypothalamus (in
particular, the lateral hypothalamic nucleus, arcuate nucleus,
and ventromedial nucleus). Outside the brain, phentermine releases norepinephrine and epinephrine –
also known as noradrenaline and adrenaline respectively – causing fat cells to
break down stored fat as well.

Phentermine is used for a short period of time to promote
weight loss, if exercise and calorie reduction are not sufficient, and in
addition to exercise and calorie reduction.

Phentermine is approved for up to 12 weeks of use and most
weight loss occurs in the first weeks. However, significant loss continues
through the sixth month and has been shown to continue at a slower rate through
the ninth month.

Dosage should be individualized to obtain an adequate
response with the lowest effective dose.

The usual adult dose is one capsule (37.5 mg) daily as
prescribed by the physician, administered before breakfast or 1 to 2 hours
after breakfast for appetite control.

The usual adult dose is one tablet (37.5 mg) daily as
prescribed by the physician, administered before breakfast or 1 to 2 hours
after breakfast. The dosage may be adjusted to the patient’s need. For some
patients, half tablet (18.75 mg) daily may be adequate, while in some cases it
may be desirable to give half tablets (18.75 mg) two times a day.

ADIPEX-P® is not recommended for use in
pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the
possibility of resulting insomnia.

Phentermine is related chemically and pharmacologically to
the amphetamines. Amphetamines and other stimulant drugs have been extensively
abused and the possibility of abuse of phentermine should be kept in mind when
evaluating the desirability of including a drug as part of a weight reduction
program.

Dependence

Abuse of amphetamines and related drugs may be associated
with intense psychological dependence and severe social dysfunction. There are
reports of patients who have increased the dosage of these drugs to many times
that recommended. Abrupt cessation following prolonged high dosage
administration results in extreme fatigue and mental depression; changes are
also noted on the sleep EEG. Manifestations of chronic intoxication
with anorectic drugs include severe dermatoses, marked insomnia,
irritability, hyperactivity and personality changes. A severe
manifestation of chronic intoxication is psychosis, often clinically
indistinguishable from schizophrenia.

Adipex-P® is best stored at room temperature away from
direct light and moisture. To prevent drug damage, you should not store
Adipex-P® in the bathroom or the freezer. There may be different brands of
Adipex-P® that may have different storage needs. It is important to always
check the product package for instructions on storage, or ask your pharmacist.
For safety, you should keep all medicines away from children and pets.

ADIPEX-P® is indicated only as short-term (a
few weeks ) monotherapy for the management of exogenous obesity. The safety and
efficacy of combination therapy with ADIPEX-P® and any other
drug products for weight loss including prescribed drugs, over-the-counter
preparations, and herbal products, or serotonergic agents such as selective
serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine,
paroxetine), have not been established. Therefore, coadministration of ADIPEX-P® and
these drug products is not recommended.

Primary Pulmonary
Hypertension

Primary Pulmonary Hypertension (PPH) – a rare, frequently
fatal disease of the lungs – has been reported to occur in patients receiving a
combination of phentermine with fenfluramine or dexfenfluramine. The
possibility of an association between PPH and the use of ADIPEX-P® alone
cannot be ruled out; there have been rare cases of PPH in patients who
reportedly have taken phentermine alone. The initial symptom of PPH is
usually dyspnea. Other initial symptoms may include angina pectoris, syncope or
lower extremity edema. Patients should be advised to report immediately any
deterioration in exercise tolerance. Treatment should be discontinued in
patients who develop new, unexplained symptoms of dyspnea, angina pectoris,
syncope or lower extremity edema, and patients should be evaluated for the
possible presence of pulmonary hypertension.

Valvular Heart
Disease

Serious regurgitant cardiac valvular disease, primarily
affecting the mitral, aortic and/or tricus pid valves, has been reported in
otherwise healthy persons who had taken a combination of phentermine with fenfluramine
or dexfenfluramine for weight loss. The possible role of phentermine in the
etiology of these valvulopathies has not been established and their course in
individuals after the drugs are stopped is not known. The possibility of an
association between valvular heart disease and the use of ADIPEX-P® alone
cannot be ruled out; there have been rare cases of valvular heart disease in
patients who reportedly have taken phentermine alone.

Development Of
Tolerance, Discontinuation In Case Of Tolerance

When tolerance to the anorectant effect develops, the
recommended dose should not be exceeded in an attempt to increase the effect;
rather, the drug should be discontinued.

Effect On The Ability
To Engage In Potentially Hazardous Tasks

ADIPEX-P® may impair the ability of the
patient to engage in potentially hazardous activities such as operating
machinery or driving a motor vehicle; the patient should therefore be cautioned
accordingly.

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